ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials (Papers: Tanya J. Symons, et al | November 2019)0

Posted by Admin in on December 17, 2019
 

Abstract

There is intense debate around the use of altered and waived consent for pragmatic trials. Those in favor argue that traditional consent compromises the internal and external validity of these trials. Those against, warn that the resultant loss of autonomy compromises respect for persons and could undermine trust in the research enterprise.

This article examines whether international ethical guidelines and the policy frameworks in three countries—the United States, England, and Australia—permit altered and waived consent for minimal-risk pragmatic trials conducted outside the emergency setting. Provisions for both are clearly articulated in U.S. regulations, but many countries do not have equivalent frameworks. Investigators should not assume that all consent models permitted in the United States are legal in their jurisdictions, even if they are deemed ethically defensible.

The authors summarize ethical and regulatory considerations and present a framework for investigators contemplating trials with altered or waived consent.

Symons, T.J., Zeps, N., Myles, P.S., Morris, J.M. & Sessler, D.I. (2019) International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials. Anesthesiology 2020;132(1):44-54. doi: https://doi.org/10.1097/ALN.0000000000003020.
Publisher: https://anesthesiology.pubs.asahq.org/article.aspx?articleid=2756350

Breakthrough Gene Therapy Clinical Trial is the World’s First That Aims to Reverse 20 Years of Aging in Humans – CISION (Osvaldo R. Martinez-Clark | November 2019)0

Posted by Admin in on November 28, 2019
 

This is the world’s first IRB-approved clinical trial aimed at reversing aging by at least 20 years; it is also the world’s most expensive pay-to-play trial with a one million price tag to enroll.

This isn’t a human research ethics vignette/scenario, but could very easily be used as the basis for a discussion with researchers, research ethics reviewers, research ethics advisers, or research office staff about:
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  1. Pay-to-play clinical trials
  2. Appropriate recruitment materials
  3. The use of ethics approval as a sales tool
  4. The conduct of trials in another country

MANHATTAN, Kan., Nov. 21, 2019 /PRNewswire/ — Libella Gene Therapeutics, LLC (“Libella”) announces an institutional review board (IRB)-approved pay-to-play clinical trial in Colombia (South America) using gene therapy that aims to treat and ultimately cure aging. This could lead to Libella offering the world’s only treatment to cure and reverse aging by 20 years.
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Under Libella’s pay-to-play model, trial participants will be enrolled in their country of origin after paying $1 million. Participants will travel to Colombia to sign their informed consent and to receive the Libella gene therapy under a strictly controlled hospital environment.
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Traditionally, aging has been viewed as a natural process. This view has shifted, and now scientists believe that aging should be seen as a disease. The research in this field has led to the belief that the kingpin of aging in humans is the shortening of our telomeres.
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Telomeres are the body’s biological clock. Every time a cell divides, telomeres shorten, and our cells become less efficient at dividing again. This is why we age. A significant number of scientific peer-reviewed studies have confirmed this. Some of these studies have shown actual age reversal in every way imaginable simply by lengthening telomeres.
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Why research ethics should add retrospective review (Papers: Angus Dawson, et al | October 2019)0

Posted by Admin in on October 26, 2019
 

Abstract
Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a few well-established ethical issues that researchers need to address to obtain ethical approval to begin their research. While such prospective review of research is important, we argue that it is not sufficient to address all aspects of research ethics. We propose retrospective review as an important complement to prospective review. We offer two arguments to support our claim that prospective review is insufficient. First, as currently practiced, research ethics has become for some a ‘tick box’ exercise to get over the ‘hurdle’ of ethics approval. This fails to capture much of what is important in ethics and does not promote careful reflection on the ethical issues involved. Second, the current approach tends to be rules-based and we argue that research ethics should go beyond this to develop people’s capacity to be sensitive to the relevant moral features of their research, their ethical decision-making skills and their integrity. Retrospective review of a project’s ethical issues, and how they were addressed, could help to achieve those aims better. We believe that a broad range of stakeholders should be involved in such retrospective review, including representatives of ethics committees, participating communities and those involved in the research. All stakeholders could then learn from others’ perspectives and experiences. An open and transparent assessment of research could help to promote trust and understanding between stakeholders, as well as identifying areas of agreement and disagreement and how these can be built upon or addressed. Retrospective review also has the potential to promote critical reflection on ethics and help to develop ethical sensitivity and integrity within the research team. Demonstrating this would take empirical evidence and we suggest that any such initiatives should be accompanied by research into their effectiveness. Our article concludes with a discussion of some possible objections to our proposal, and an invitation to further debate and discussion.

Dawson, A., Lignou, S., Siriwardhana, C. and O’Mathúna, D.P. (2019) Why research ethics should add retrospective review. BMC Medical Ethics 20: 68
Publisher (Open Access): https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-019-0399-1

Enhancing ethics review of social and behavioral research: developing a review template in Ethiopia (Papers: Liya Wassie, et al | August 2019)0

Posted by Admin in on September 1, 2019
 

Abstract

Background:
Africa is increasingly becoming an important region for health research, mainly due to its heavy burden of disease, socioeconomic challenges, and inadequate health facilities. Regulatory capacities, in terms of ethical review processes, are also generally weak. The ethical assessment of social and behavioral research is relatively neglected compared to the review of biomedical and clinical studies, which led us to develop an ethics review assessment tool for use in the review of social and behavioral research in Ethiopia, which could potentially be of value in low- and middle-income settings.

Methods:
Initially, we did a comprehensive literature review on principles, guidelines, and practices of research ethics, on social and behavioral studies, from which we extracted query terms to explore the opinions of selected key informants and focus groups in Ethiopia. The discussants and informants were selected using a convenience sampling method to evaluate an ethics review template, which integrated issues that commonly arise in social and behavioral studies. Finally, we directly solicited opinions from the discussants about the desirability, feasibility, acceptability, and relevance of the ethics review assessment tool and used the resulting data to refine our initial draft.

Results and conclusion:
Although the same basic ethics principles govern all research studies, social and behavioral research have some disciplinary particularities that may require reviewers to exercise a different orientation of ethical attention in some cases. Using a qualitative approach, we developed a review assessment tool that could potentially be useful to raise awareness, focus attention, and strengthen the review of social and behavioral studies by ethics review committees, particularly in settings without a long-standing tradition of reviewing such research. This process also exposed some areas where further capacity building and discussion of ethical issues may be necessary among stakeholders in the review of social and behavioral research.

Keywords
Behavioral, social, qualitative, biomedical research, ethics review, low and middle income

Liya Wassie, Senkenesh Gebre-Mariam, Geremew Terekegne et al. (2019) Enhancing ethics review of social and behavioural research: Developing a review template in Ethiopia. Research Ethics 15(4) 1–23.
Publisher (Open Access): https://journals.sagepub.com/doi/full/10.1177/1747016119865731

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